Method and apparatus for treating pelvic organ prolapses in female patients

ABSTRACT

An anterior implant adapted to treat central and lateral cystoceles present in a female patient includes laterally extending stabilizing straps for supporting the implant between the patient&#39;s bladder and vagina independently of the patient&#39;s arcus tendineous fascia pelvis. Rectocele and hysterocele repairs can be carried out using a single posterior implant which, like the anterior implant, is provided with laterally extending stabilizing straps for supporting the implant between the patient&#39;s rectum and vagina.

CROSS REFERENCE TO RELATED APPLICATION

[0001] This is a § 111(a) application relating to U.S. Appln. Serial No.60/361,503 filed Mar. 1, 2002.

FIELD OF THE INVENTION

[0002] The present invention relates to surgical devices and proceduresuseful for treating pelvic organ prolapses in female patients.

BACKGROUND OF THE INVENTION

[0003] Women, often due to age, can experience three basic types ofpelvic organ prolapses. These prolapses or defects are as follows:cystocele; hysterocele; and rectocele.

[0004] A cystocele occurs when the bladder bulges into the vagina. Ifthe defect is confined, to a centralized region, it is commonly referredto as a central cystocele. If the defect extends laterally beyond anysuch centralized region, the laterally extending portion(s) is commonlyreferred to as a lateral cystocele(s). Cystoceles, in general, aretreated by an anterior repair which, in the past, has involved asuturing procedure or the use of an implant adapted to support thebladder in a hammock-like fashion (see, for instance, U.S. Pat. No.5,840,011 and WIPO Publication No. WO 02/38079 A2). The known suturingprocedures suffer from a high re-occurrence rate. The aforementionedimplants, while having proved successful for the treatment of a centralcystocele, are not inherently designed to treat a lateral cystocele(s).

[0005] A rectocele occurs when the rectum bulges into the vagina. Thistype of defect is treated by a posterior repair which, in the past, hasinvolved suspension of the vaginal apex to the cardinal and uterosacralligaments. Variations of these procedures have been performed usingvarious mesh materials.

[0006] A hysterocele occurs when the uterus descends into the vagina,resulting in a vaginal vault descent. The common treatment for such adefect is a hysterectomy, followed with a vaginal vault suspensioncarried out by, for instance, attaching the resulting vaginal cuff tothe levator ani, to the cocuygenous muscle, or to one of thesacrospinous ligaments, but not to both of them (the Richter technique).

SUMMARY OF THE INVENTION

[0007] One aspect of the present invention involves a new and improvedanterior implant and a procedure for using it to make cystocele repairsin a female patient. More particularly, the anterior implant includes aninboard area adapted to treat a lateral cystocele and a pair of flankingoutboard areas, each of which is adapted to treat a lateral cystocele.After positioning the body of the anterior implant between the patient'sbladder and vagina, laterally extending straps are passed through thepatient's obturator foramens and corresponding skin incisions in thepatient's perineum. The straps function to stabilize the anteriorimplant on both sides thereof independently of the patient's arcustendineous fascia pelvis. In one embodiment, the anterior implant isprovided with a pair of stabilizing straps, one on each side of theimplant. In another embodiment, two pairs of stabilizing straps areprovided, one pair extending laterally from one side of the anteriorimplant and another pair extending laterally from the opposite side ofthe anterior implant.

[0008] Another aspect of the present invention involves a new andimproved posterior implant and a procedure for using it to treat arectocele and/or a hysterocele present in a female patient. Theposterior implant includes laterally extending straps for supporting thebody of the posterior implant between the rectum and the vagina, whilealso functioning to perform a vaginal vault suspension through theirattachment to the sacrospinous ligaments.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] For a better understanding of the present invention, reference ismade to the following detailed description of various exemplaryembodiments considered in conjunction with the accompanying drawings, inwhich:

[0010]FIG. 1 is a top plan view of one exemplary embodiment of ananterior implant constructed in accordance with the present invention;

[0011]FIG. 2 is a top plan view of one exemplary embodiment of aposterior implant constructed in accordance with the present invention;

[0012]FIG. 3 is an illustration of a female's pelvic anatomy which hasundergone surgical procedures using the implants of FIGS. 1 and 2;

[0013]FIGS. 4 and 5 illustrate two stages of a trans-obturator passagewhich is being performed as part of the surgical procedures depicted inFIG. 3;

[0014]FIG. 6 shows the implants of FIGS. 1 and 2 as they are beingimplanted in a female patient;

[0015]FIG. 7 shows the anterior implant of FIG. 1 in place between afemale patient's bladder and vagina;

[0016]FIGS. 8 and 9 show the posterior implant of FIG. 2 in placebetween a female patient's rectum and vagina;

[0017]FIG. 10 is a top plan view of another exemplary embodiment of ananterior implant constructed in accordance with the present invention;and

[0018]FIG. 11 is a top plan view of another exemplary embodiment of aposterior implant constructed in accordance with the present invention.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0019] With reference to FIG. 1, an anterior implant 10 includes a lowerportion 12 and an upper portion 14. While two distinct portions havebeen identified, it should be understood that the anterior implant 10 ispreferably made from a single sheet of any suitable bio-compatible meshmaterial, such as a knitted polypropylene fabric (e.g., soft PROLENE®mesh marketed by Ethicon, Inc. of Somerville, N.J., U.S.A.).Accordingly, the imaginary boundaries of the various portions areindicated in FIG. 1 by dotted lines (i.e., in phantom) to facilitateconsideration and discussion of the anterior implant 10.

[0020] Returning now to FIG. 1, the lower portion 12, which has agenerally funnel-like shape, is demarcated by a straight lower edge 16having a length in a range of from about 2 cm to about 5 cm, animaginary border 18 (indicated in phantom in FIG. 1) having a length ina range of from about 8 cm to about 14 cm, and a pair of concave sideedges 20, 22 having a complex (i.e., compound) arcuate shapeapproximating that of a female patient's pelvic anatomy. Corners 24, 26are formed where the lower edge 16 merges with the concave side edges20, 22, respectively. It should be noted that the lower edge 16 can beextended by as much as about 3 cm (as indicated in phantom in FIG. 1)for a purpose to be described hereinafter.

[0021] The distance D₁ between the lower edge 16 and the imaginaryborder 18 is also selected as a function of the pelvic anatomy of thepatient, but typically falls within a range of from about 4 cm to about8 cm. Of course, the nature of the mesh fabric from which the anteriorimplant 10 is made is such that the surgeon can modify the size andshape of the lower portion 12 to meet the needs of a particular patient.In other words, the lower portion 12 of the anterior implant 10 can becustom fitted in the surgical arena.

[0022] Still referring to FIG. 1, the upper portion 14, which has agenerally dome-like shape, is demarcated by the imaginary border 18 withthe lower portion 12, a curved upper edge 28 having a radius (e.g., fromabout 2 cm to about 4 cm) and arcuate length (e.g., from about 2 cm toabout 4 cm) selected so as to avoid contact with the bladder neck of thepatient, and a pair of convex side edges 30, 32 having a complex arcuateshape approximating that of the arcus tendineous fascia pelvic (ATFP).The convex side edges 30, 32 of the upper portion 14 merge with theconcave side edges 20, 22, respectively, of the lower portion 12 to formcorners 34, 36, respectively, while corners 38, 40 are formed where theupper edge 28 merges with the convex side edges 30, 32, respectively.

[0023] The distance D₂, as measured along the central longitudinal axis(L) of the anterior implant 10 and between the imaginary border 18 andthe upper edge 28, is selected as a function of the pelvic anatomy ofthe patient. Typically, the distance D₂ falls within a range of fromabout 3 cm to about 5 cm. Like the lower portion 12, the upper portion14 is adapted for custom fitting in the surgical arena to meet theparticular needs of a patient. Thus, it should be understood that theshape and size of the upper portion 14 are subject to post-manufacturemodification by the surgeon during the course of a surgical procedure.

[0024] With continuing reference to FIG. 1, straps 42, 44 extendoutwardly from opposite sides of the upper portion 14. Moreparticularly, the strap 42 extends laterally outward from the convexside edge 30 of the upper portion 14, while the strap 44 extendslaterally outward from the convex side edge 32 of the upper portion 14.The straps 42, 44, whose function will be described in detailhereinafter, typically have a width in a range of from about 0.5 cm toabout 2 cm, and a length in a range of from about 7 cm to about 15 cm.While the straps 42, 44 preferably have a slight curvature as shown inFIG. 1, they could also extend in a linear fashion from the convex sidesedges 30, 32, respectively, of the anterior implant 10. As explainedpreviously, the surgeon can readily modify the width and length of thestraps 42, 44 by, for instance, cutting them with scissors or othersuitable cutting instruments.

[0025] Imaginary boundary lines 46, 48, which extend generally parallelto the central longitudinal axis (L), divide the body of the anteriorimplant 10 into an inboard area A₁ and two outboard areas A₂, A₃ whichflank the inboard area A₁. The areas A₁, A₂, and A₃ are not precise.Generally speaking, the area A₁ designates that portion of the anteriorimplant 10 which would function to repair a central or medial cystocelein accordance with a surgical procedure to be described in detailhereinafter, while the areas A₂, A₃ designate those portions of theanterior implant 10 which would function to repair lateral cystoceles inaccordance with the same procedure.

[0026] With reference now to FIG. 2, a posterior implant 50 includes alower portion 52, an upper portion 54, and a tape portion 56. Like theanterior implant 10, the posterior implant 50 is made from a singlesheet of any suitable bio-compatible mesh material. Although theposterior implant 50 is depicted in FIG. 2 as being separate anddistinct from the anterior implant 10, it should be understood that theposterior implant 50 can be formed integrally with the anterior implant10 as will be described in greater detail hereinafter. As was the casewhen describing the anterior implant 10 of FIG. 1, the imaginaryboundaries of the various portions of the posterior implant 50 of FIG. 2are indicated by dotted lines (i.e., in phantom) to facilitateconsideration and discussion.

[0027] Returning now to FIG. 2, the tape portion 56, which is interposedbetween the lower portion 52 and the upper portion 54, has an imaginarycentral region 58 bounded by imaginary lines 60, 62, 64 and 66 andapproximating the shape of a rectangle having a length of about 5 cm anda width of about 0.5 to 2 cm. The tape portion 56 also includes a pairof straps 68, 70 extending outwardly from opposite ends of the imaginarycentral region 58. The straps 68, 70, whose function will be describedin greater detail hereinafter, typically have a width in a range of fromabout 0.5 cm to about 2 cm, a length of about 4 cm, if the straps 68, 70are attached to and terminated at the sacrospinous ligaments, or about20 cm, if the straps 68, 70 are passed through the pelvic floor via thebuttocks with or without passing through the sacrospinous ligaments.While the straps 68, 70 preferably have a slight curvature as shown inFIG. 2, they could also extend in a linear fashion from opposite sidesof posterior implant 50. Given the nature of the mesh material fromwhich the posterior implant 50 is made, the width and length of thestraps 68, 70 can be readily modified by the surgeon to meet the needsof a particular patient.

[0028] Still referring to FIG. 2, the lower portion 52, which has agenerally triangular shape, depends downwardly from the tape portion 56.More particularly, the lower portion 52 is demarcated by a straightlower edge 72 having a length in a range of from about 1.5 cm to about3.5 cm and a pair of downwardly converging side edges 74, 76 which areeither straight or slightly concave. While the length of the side edges74, 76 is typically in a range of from about 8 cm to about 12 cm, itshould be appreciated by a person skilled in the art that the physicaldimensions of the lower portion 52, including the length of the sideedges 74, 76, are a function of the pelvic anatomy of the patient. Moreparticularly, the size and shape of the lower portion 52 arespecifically selected for the purpose of repairing a rectocele. A personskilled in the art will also appreciate that the shape and size of thelower portion 52 are subject to post-manufacture modification by thesurgeon. In cases where a rectocele repair is not required but a vaginalvault suspension is, both the lower portion 52 and the upper portion 54can be removed from the posterior implant 50, leaving the tape portion56 to perform the vaginal vault suspension.

[0029] With continuing reference to FIG. 2, the upper portion 54, whichis demarcated at its free end by an upper edge 78 and which otherwiseapproximates the shape of a rectangle having a length of from about 3 cmand a width of about 1 cm, extends upwardly from the tape portion 56.The primary purpose of the upper portion 54 is to provide a means forattaching the posterior implant 50 to the anterior implant 10. Thus, fora patient who does not need the anterior implant 10, it should beappreciated that the upper portion 54 of the posterior implant 50 can beremoved by the surgeon before insertion of the posterior implant 50 insuch patient. It should also be appreciated that the surgeon canotherwise modify the size and shape of the upper portion 54 to meet hisor her needs, such as when attaching the posterior implant 50 to theanterior implant 10. For instance, the upper edge 78 can be extended byas much as about 3 cm (as indicated in phantom in FIG. 2) to facilitateattachment of the posterior implant 50 to the anterior implant 10.Alternatively, such attachment can be facilitated by extending the loweredge 16 of the anterior implant 10 as described hereinabove.

[0030] Both the anterior implant 10 and the posterior implant 50 can becut or punched out from a larger piece of the mesh fabrics mentionedhereinabove. If necessary, the loose ends of the severed filaments canbe treated against unravelling by any suitable technique known in theart.

[0031] The anterior implant 10 and the posterior implant 50 may beprovided in a variety of standard shapes and sizes (e.g., small, mediumand large). After comparing these standard implants to the pelvicanatomy of a particular patient, the surgeon would select the one whichbest meets the patient's needs. If any modifications to the size and/orshape of the selected implant are required, they can be effected by thesurgeon in the surgical arena.

[0032] The anterior implant 10 is used to make an anterior repair of acystocele, while the posterior implant 50 is used to make a posteriorrepair of a rectocele. A vaginal vault suspension can be performed usingthe anterior implant 10 and/or the posterior implant 50. All of thesetreatments will be discussed in greater detail below.

[0033] I. Overview

[0034] A standard vaginal hysterectomy usually precedes any pelvic floorrepair carried out in accordance with the present invention. Thus, asshown in FIG. 3, a vagina (V) is illustrated without its associateduterus.

[0035] Referring still to FIG. 3, a cystocele has been treated by ananterior repair performed with the anterior implant 10 of FIG. 1.Briefly, such a treatment involves the placement of the anterior implant10 between the vagina (V) and the bladder (B).

[0036]FIG. 3 also illustrates how a rectocele has been treated by aposterior repair performed with the posterior implant 50 of FIG. 2.Briefly, such a treatment involves the placement of the anterior implant50 between the vagina (V) and the rectum (R).

[0037] Since the uterus (not shown) has been removed from the vagina(V), an apical repair is also illustrated in FIG. 3. Briefly, such arepair involves using the anterior implant 10 and/or the posteriorimplant 50 to perform a vaginal vault suspension.

[0038] II. Anterior and Lateral Repair

[0039] A. Incision of the Anterior Vaginal Wall

[0040] The full thickness of the anterior vaginal wall is incisedlongitudinally to create an appropriately sized anterior vaginalincision. If respecting the bladder neck area and the apical part of thevagina, the anterior median colpotomy would start 3 cm from the vaginalvault and would stop at least 1 cm from the bladder neck. If respectingthe bladder neck area only, the anterior median colpotomy would start atthe vaginal vault and would stop at least 1 cm from the bladder neck.Although not illustrated in the accompanying drawings, these proceduresare well known to a person skilled in the art.

[0041] B. Bladder Dissection

[0042] This well known procedure, which is not illustrated in theaccompanying drawings, involves a lateral dissection up to the vaginalcul-de-sac. The integrity of the endopelvic fascia is then checked.

[0043] In the absence of a defect, the dissection is carried outfollowing the plane of the fascia until the inferior edge of the pubicramus is reached. After inserting scissors between the levator ani andthe bone, a finger is passed through the opening and then pushed untilit comes into contact with the obturator membrane. Such a procedure iscommonly referred to as a supra levator passage.

[0044] If, on the other hand, a lateral defect or a very weak fascia isfound, the paravesical fossa is first opened with a finger. Since acomplete dissection of the arcus tendinosus fascia pelvis isunnecessary, the finger feels the obturator foramen through the muscularpelvic side wall (levator ani and obturator muscles). Such a procedureis commonly referred to as a trans-levator passage.

[0045] C. Plication of the Pre-Vesical Fascia

[0046] This procedure is typically performed using a continuous sutureof 2/0 absorbable monofilament suture. While not illustrated in theaccompanying drawings, the procedure is well known to a person skilledin the art.

[0047] D. Trans-Obturator Passage

[0048] This procedure is illustrated in FIGS. 4 and 5. The ideal zonefor such a passage is the inferior and internal part of the obturatorforamen, slightly above the ischio-pubic ramus (PR). It is located atthe level of the arcus tendinosus internally and can be surgicallydefined by a bi-digital palpation.

[0049] Referring to FIG. 4, the surgeon would use a surgical knife (K),such as a scalpel, to make a 5 mm skin incision (SI₁), facing the tip ofthe surgeon's index finger (IF) lateral to the labia majora. Aconventional curved and eyed needle (N) adapted to carry a suture (S₁)is passed through the obturator foramen (OF) and then pushed around theischio-pubic ramus (PR) until it comes into contact with the tip of thesurgeon's index finger (IF).

[0050] With reference now to FIG. 5, the needle (N) is guided by thesurgeon's index finger (IF) and pushed through the anterior vaginalincision (not shown) until it reaches the vaginal opening (VO). Thesurgeon can now hook the looped end of the suture (S₁) with his or herindex finger, pulling it out of the patient through the vaginal opening(VO). After detaching the suture (S₁) from the needle (N) andwithdrawing the needle (N) back through the skin incision (SI₁), thesuture (S₁) lies freely in the trans-obturator passage ready forattachment to the anterior implant 10 of FIG. 1 as will be describedhereinafter.

[0051] The same procedure would then be performed on the opposite sideof the patient using the same needle (N) or another identical needle.The result would be that there are now two sutures (S₁) and (S₂)extending from two skin incisions (SI₁) and (SI₂) to the vaginal opening(VO), where they are ready for attachment to the anterior implant 10(see FIG. 6).

[0052] E. Anterior Implant Fixation

[0053] With particular reference to FIG. 6, the two sutures (S₁) and(S₂) are shown attached to the straps 42, 44, respectively, of theanterior implant 10. As illustrated in FIG. 6, both of the sutures (S₁)and (S₂) are pulled on in the direction of arrows AR₁ and AR₂,respectively, while the surgeon inserts the anterior implant 10 into thepatient through the vaginal opening (VO) and then through the anteriorvaginal incision (not shown). As the sutures (S₁) and (S₂) are continuedto be withdrawn back through the skin incisions (SI₁) and (SI₂),respectively, the straps 42, 44 pass through their respective obturatormembranes, finally emerging through the skin incisions (SI₁) and (SI₂),respectively. Each of the straps 42, 44 is given the correct tension sothat the anterior implant 10 conforms as much as possible to thepatient's surrounding tissues. The straps 42, 44 are then cut at skinlevel and abandoned without any additional fixation. The anteriorimplant 10 would now be laterally fixated between the bladder (B) andthe vagina (V) as shown in FIG. 3. When the endopelvic fascia is strong,the straps 42, 44 can be severed from the anterior implant 10, therebyavoiding the trans-obturator passage. In such a situation, the anteriorimplant 10 would be fixed laterally by two stitches on each of itssides.

[0054] Referring now to FIG. 7, as well as to FIG. 3, the anteriorimplant 10 is fixed bilaterally, in the vicinity of the corners 38, 40,to the anterior part of the pubo-coccygeous muscle (PM) close to itsinsertion by one stitch of braided absorbable size 0 suture, therebyachieving an anterior fixation of the implant. The anterior implant 10is also fixed bilaterally, in the vicinity of the corners 24, 26, to theutero-sacral ligaments (US₁) and (US₂) a distance of 1 to 2 cm from thevaginal cuff (VC) by one stitch of braided absorbable size 0 suture.Alternatively, such posterior fixation of the anterior implant 10 can beachieved by attachment to the sacro-spinous ligaments (SS₁) and (SS₂)bilaterally or to the posterior implant 50, if a posterior repair is tobe performed.

[0055] If no posterior repair is to be undertaken, an economicalcolpectomy, which would be limited to the edges of the vaginal incision,is performed as required. The anterior vaginal incision is then closed(as shown in FIGS. 3 and 7) by a continuous absorbable size 0 suture upto the vaginal apex, making sure that the vaginal wall is not undertension.

[0056] With continuing reference to FIGS. 3 and 7, a person skilled inthe art will readily appreciate that the anterior implant 10 functionsto repair lateral cystoceles, as well as a medial or central cystocele.It should also be understood that the straps 42, 44 of the anteriorimplant 10 provide adequate lateral fixation so as to eliminate the needto stitch or staple the convex side edges 30, 32 to the arcus tendineousfascia pelvis (ATFP), thereby avoiding a very difficult andtime-consuming stitching or stapling procedure.

[0057] III. Posterior Repair

[0058] A. Incision of the Perineum

[0059] This procedure, which is well known in the art and which is notdepicted in the accompanying drawings, involves two basic steps. Thesesteps are as follows: (1) the triangular incision of the perineal skinand excision; and (2) dissection of the perineal body.

[0060] B. Incision of the Posterior Vaginal Wall

[0061] The full thickness of the posterior vaginal wall is incisedlongitudinally from the perineal incision either up to 2 cm from thevaginal apex or up to the vaginal apex, thereby creating anappropriately sized posterior vaginal incision. While this procedure isnot illustrated in the accompanying drawings, it is well known in theart.

[0062] C. Rectal Dissection

[0063] The anterior and lateral wall of the rectum is bluntly dissectedfrom the vagina. Since this procedure is well known to a person skilledin the art, it has not been depicted in the accompanying drawings.

[0064] D. Para-Rectal Space Dissection

[0065] Initially, the para-rectal space is entered bilaterally by gentledissection. It is then dissected more deeply until the sacro-spinuousligaments are exposed or simply palpated. Again, while this procedure isnot illustrated in the accompanying drawings, it is well known in theart.

[0066] E. Plication of the Pre-Rectal Fascia

[0067] This procedure is typically performed using a continuous sutureof 2/0 absorbable monofilament suture. Because this procedure is wellknown in the art, it too has not been depicted in the accompanyingdrawings.

[0068] F. Posterior Implant Fixation

[0069] With reference to FIG. 6, lateral fixation of the posteriorimplant 50 of FIG. 2 is achieved by inserting non-absorbable size 0braided sutures (BS₁) and (BS₂) into the sacro-spinous ligaments (SS₁)and (SS₂), respectively, 2 to 3 cm medial to the sciatic spine on bothsides of the patient's body. After attaching the straps 68, 70 of theposterior implant 50 to the braided sutures (BS₁) and (BS₂),respectively, the implant is inserted into the patient's body throughthe vaginal opening (VO) and then through the posterior vaginal incision(not shown). The braided sutures (BS₁) and (BS₂) are then used to attachtheir associated straps 68, 70 to the sacro-spinous ligaments (SS₁) and(SS₂), respectively, such that the posterior implant 50 is positionedbetween the vagina (V) and the rectum (R) as illustrated best in FIG. 8.It is also possible to attach the straps 68, 70 to the sacro-spinousligaments (SS₁) and (SS₂) using glue, staples, tacks, anchors (e.g.,MITEK's “Fastin” threaded anchor or INFLUENCE's “Raz” soft-tissueanchoring system) or sewing devices such as United States SurgicalCorporation's “Endostitch” mechanism.

[0070] Referring now to FIG. 8, as well as to FIG. 3, upper fixation ofthe posterior implant 50 is achieved by applying the upper portion 54 tothe anterior wall of the high rectum without any fixation.Alternatively, and with reference to FIG. 3, the upper portion 54 of theposterior implant 50 can be fixed to the utero-sacral ligaments (US₁)and (US₂) by stitching or any other suitable means known in the art; or,if an anterior repair has been performed, it can be folded over thevaginal cuff (VC) and then attached to the lower portion 12 of theanterior implant 10 between the corners 24, 26 thereof.

[0071] With continuing reference to FIGS. 3, 8 and 9, lower fixation ofthe posterior implant 50 is achieved by applying the lower portion 52 ofthe implant to the anterior wall of the mid and low rectum. The edges74, 76 of the lower portion 52 are fixed to the pubo-rectal muscle byone or two stitches of absorbable braided 2/0 sutures (see FIGS. 3 and8). The lower edge 72 (i.e., the free end) of the lower portion 52 isattached to the perineal body (see FIG. 9) in order to treat or preventassociated descending perineum.

[0072] With the posterior implant 50 properly positioned between thevagina (V) and the rectum (R), the posterior repair is now complete.Closure of the posterior vaginal incision (not shown) is typicallyachieved by a continuous absorbable size 0 suture starting at thevaginal apex, making sure that the posterior vaginal wall is not undertension. A standard perineorraphy is then performed covering the distalpart of the posterior implant 50.

[0073] IV. Apical Repair

[0074] Apical fixation can be performed in accordance with threedifferent techniques. Each of these techniques will be described below.

[0075] In accordance with one technique, the vaginal vault is fixed bythe attachment between the utero-sacral ligaments and the anteriorimplant 10 and/or the posterior implant 50 (see FIG. 3). The suture isapplied transversely, if the utero-sacral ligaments remain distinct, orlongitudinally, if such ligaments have been brought together as per theMcCall-type culdeplasty.

[0076] Another technique involves attaching the vaginal vault to theanterior implant 10 and/or the posterior implant 50 by trans-fixatingabsorbable 2/0 braided sutures. Like the preceding technique, thistechnique uses one or both of the implants 10, 50 to achieve the desiredapical fixation.

[0077] The other apical fixation technique does not make direct use ofeither the anterior implant 10 or the posterior implant 50. Moreparticularly, the vaginal vault is fixed independently of either of theimplants 10, 50 by a standard bilateral sacro-spinous fixation.

[0078] What follows is a description of the two alternate embodimentsreferred to above and illustrated in FIGS. 10 and 11. In describingthese alternate embodiments, elements which correspond to elementsdescribed above in connection with the embodiments of FIGS. 1 and 2 willbe designated by corresponding reference numerals increased by onehundred. Unless otherwise specified, the alternate embodiments of FIGS.10 and 11 are constructed and operate in the same manner as theembodiments of FIGS. 1 and 2, respectively.

[0079] Referring to FIG. 10, there is shown an anterior implant 110whose main difference in comparison to the anterior implant 10 of FIG. 1involves the provision of two straps 142 on one side of the anteriorimplant 110 and two straps 144 on the opposite side of the anteriorplant 110. Both of the straps 142 pass through the obturator foramen onone side of a patient, while both of the straps 144 pass through theobturator foramen on the other side of the patient's body. Each of thestraps 142 exits the patient's body through a corresponding one of twosmall skin incisions at the perineum (i.e., groin) on one side of thebody. Similarly, each of the straps 144 exits the patient's body througha corresponding one of two small skin incisions at the perineum (i.e.,groin) on the other side of the body. As compared with the anteriorimplant 10, the anterior implant 110 provides increased lateral supportin use as a result of the provision of the extra set of straps 142, 144,whose location allows the anterior implant 110 to be manufacturedwithout the corners 34, 36 and 38, 40 which are characteristic of theanterior implant 10.

[0080] With reference to FIG. 11, there is shown a posterior implant 150whose main difference in comparison to the posterior implant 50 of FIG.2 involves the acute angle that straps 168, 170 form with the centrallongitudinal axis (L) of the anterior implant 150. The angle isspecifically selected so as to reduce the amount of rectal constrictionin the event that the posterior implant 150 shrinks when implanted in apatient's body.

[0081] It should be understood that the various embodiments describedherein are merely exemplary and that a person skilled in the art maymake many variations and modifications without departing from the spiritand scope of the invention as defined in the appended claims. Forinstance, if the uterus is conserved (i.e., no hysterectomy), theposterior fixation of the anterior implant 10 is done on the anteriorpart of the cervix, with the upper portion 54 of the posterior implant50 being fixed on the posterior part of the cervix. Also, once theprolapse repair has been completed in accordance with the presentinvention, a vaginal incision can be made at the mid-urethral level anda sub-urethral sling inserted in accordance with a well known treatmentfor stress urinary incontinence. These and any and all additionalvariations and modifications are intended to be included within thescope of the invention as defined in the appended claims.

1. An implant for treating central and lateral cystoceles present in afemale patient, comprising a body having a central longitudinal axis, aninboard area through which said central longitudinal axis passes, saidinboard area being sized and shaped so as to repair a central cystocele,at least one outboard area positioned on at least one side of saidinboard area, said at least one outboard area being sized and shaped soas to repair a lateral cystocele, and stabilizing means for laterallystabilizing said body on both sides thereof independently of thepatient's arcus tendineous fascia pelvis.
 2. An implant according toclaim 1, wherein said stabilizing means includes at least one pair ofstraps extending laterally outward from opposite sides of said body,each of said straps being long enough to pass through a respective oneof the patient's obturator foramens and out a corresponding skinincision formed in the patient's perineum proximal thereto.
 3. Animplant according to claim 2, wherein said at least one pair of strapsincludes a first strap which extends laterally outward from one side ofsaid body and a second strap which extends laterally outward from theother side of said body.
 4. An implant according to claim 3, whereinsaid at least one outboard area includes a first outboard area on oneside of said inboard area and a second outboard area on an opposite sideof said inboard area.
 5. An implant according to claim 4, wherein saidbody includes a generally dome-shaped section having a first outer edgebordering at least a portion of said first outboard area and a secondouter edge bordering at least a portion of said second outboard area. 6.An implant according to claim 5, wherein said first strap extendslaterally outward from said first outer edge of said dome-shaped sectionand said second strap extends laterally outward from said second outeredge of said dome-shaped section.
 7. An implant according to claim 6,wherein said first outer edge has a generally convex shape whichsubstantially matches the shape of the arcus tendineous fascia pelvis onone side of the patient's body and said second outer edge has agenerally convex shape which substantially matches the shape of thearcus tendineous fascia pelvis on the other side of the patient's body.8. An implant according to claim 7, wherein said body includes agenerally funnel-shaped section having a wide portion which merges intosaid dome-shaped section at a wide end thereof and a narrow portionwhich extends away from said wide end of said dome-shaped section, saidnarrow portion being sized and shaped so as to permit attachment of saidfunnel-shaped section to the patient's utero-sacral ligaments.
 9. Animplant according to claim 8, wherein an end of said dome-shaped sectionopposite said wide end thereof includes a concave edge which merges intosaid first and second outer edges of said dome-shaped section, saidconcave edge being sized and shaped so as to, avoid contact with thepatient's bladder neck while permitting attachment of said dome-shapedsection to the patient's pubococcygeous muscle.
 10. An implant accordingto claim 9, wherein said first strap is positioned intermediate opposedends of said first outer edge of said dome-shaped section and saidsecond strap is positioned intermediate opposed ends of said secondouter edge of said dome-shaped section.
 11. An implant according toclaim 9, wherein said at least one pair of straps includes a third strapwhich extends laterally outward from said one side of said body alongsaid first outer edge of said dome-shaped section and a fourth strapwhich extends laterally outward from said other side of said body alongsaid second outer edge of said dome-shaped section.
 12. An implantaccording to claim 11, wherein said first and second straps are locatedproximal to said concave edge of said dome-shaped section and said thirdand fourth straps are located proximal to said wide end of saiddome-shaped section.
 13. An implant according to claim 2, wherein saidbody is made from a single sheet of a biocompatible mesh material,whereby said at least one pair of straps is formed monolithically withsaid body.
 14. An implant according to claim 1, wherein said body isformed monolithically with another implant adapted to treat a rectoceleand/or a hysterocele.
 15. An implant for treating a rectocele and ahysterocele present in a female patient, comprising a body having acentral longitudinal axis, a generally triangular-shaped section throughwhich said central longitudinal axis passes, said triangular-shapedsection being sized and shaped so as to repair a rectocele and having afirst edge extending along one side of said central longitudinal axisand a second edge extending along an opposite side of said centrallongitudinal axis, a first strap attached to said first edge proximal toa wide end of said triangular-shaped section and extending laterallyoutward therefrom, and a second strap attached to said second edgeproximal to said wide end of said triangular-shaped section andextending laterally outward therefrom, said first and second strapscooperating with an intermediate portion of said body to form agenerally arcuate tape-like segment sized and shaped so as to perform avaginal vault suspension.
 16. An implant according to claim 15, whereinsaid body includes attaching means for attaching said implant to anotherimplant adapted to treat a cystocele.
 17. An implant according to claim16, wherein said attaching means includes a generally rectangular-shapedsection which merges into said triangular-shaped section at said wideend thereof, said rectangular-shaped section having a dimension, asmeasured along said central longitudinal axis of said body, sufficientto permit said rectangular-shaped section to be folded over thepatient's vaginal cuff.
 18. An implant according to claim 15, whereinsaid first and second straps are long enough for attachment to thepatient's sacrospinous ligaments.
 19. An implant according to claim 15,wherein said first and second straps are long enough to extend throughand beyond the patient's sacrospinous ligaments.
 20. An implantaccording to claim 15, wherein said body is made from a single sheet ofa bio-compatible mesh material, whereby said first and second straps areformed monolithically with said triangular-shaped section.
 21. Animplant according to claim 15, wherein said body is formedmonolithically with another implant adapted to treat a cystocele.
 22. Animplant according to claim 15, wherein said first and second strapsextend toward and beyond said wide end of said triangular-shaped sectionforming an acute angle with said central longitudinal axis.
 23. Aprocedure for treating a cystocele present in a female patientcomprising the steps of: making a first skin incision in the patient'sperineum proximal to one of the obturator foramens; making a second skinincision in the patient's perineum proximal to the other obturatorforamen; providing an anterior implant with at least a pair of laterallyextending straps; inserting said anterior implant into the patient'spelvic area through the patient's vaginal opening and an anteriorincision in the vaginal wall; passing one of said straps through saidone obturator foramen and out said first skin incision; passing anotherof said straps through said other obturator foramen and out said secondskin incision; and pulling on said one strap and said another strapuntil said anterior implant is properly positioned between the patient'sbladder and vagina to repair the cystocele.
 24. A procedure according toclaim 23, further comprising the step of attaching said anterior implantto a posterior implant adapted to treat a rectocele and/or ahysterocele.
 25. A procedure according to claim 24, wherein saidanterior and posterior implants are attached to each other after theirintroduction into the patient's body.
 26. A procedure according to claim24, wherein said anterior and posterior implants are attached to eachother prior to their introduction into the patient's body.
 27. Aprocedure for treating a rectocele and a hysterocele present in a femalepatient, comprising the steps of: providing a posterior implant with apair of laterally extending straps; inserting said posterior implantinto the patient's pelvic area through the patient's vaginal opening anda posterior incision in the vaginal wall; placing said posterior implantbetween the patient's rectum and vagina to repair the rectocele;attaching one of said straps to one of the patient's sacrospinousligaments; and attaching the other of said straps to the patient's othersacrospinous ligament, thereby repairing the patient's hysterocele. 28.A procedure according to claim 27, further comprising the step ofattaching said posterior implant to an anterior implant adapted torepair a cystocele.
 29. A procedure according to claim 28, wherein saidanterior and posterior implants are attached to each other after theirintroduction into the patient's body.
 30. A procedure according to claim28, wherein said anterior and posterior implants are attached to eachother prior to their introduction into the patient's body.
 31. Aprocedure according to claim 27, wherein said one strap extends throughand beyond its associated sacrospinous ligament and said other strapextends through and beyond its associated sacrospinous ligament.